Manager Study Start Up and Regulatory Affairs
Core
Develop regulatory strategy and oversee Study Start-Up (SSU) deliverables from site selection to initiation readiness for medium to high complexity clinical projects.
Role type
Senior IC Manager, Study Start-Up and Regulatory Affairs
Builds
Clinical trial sites and regulatory compliance for early-phase rare disease and oncology trials
Domain
Clinical Research / CRO / Rare Disease & Oncology
Required skills
Global project management, Regulatory strategy, Site selection and initiation, Clinical site agreement negotiation, Risk mitigation, Budget and resource management, Proposal development, Team leadership
Preferred skills
Experience in pharmaceutical or CRO industry, Experience in regulatory body
Technologies
None stated
Responsibilities
Lead study start-up and regulatory activities ensuring alignment with timelines and quality standards; Ensure collection, review, and tracking of essential documents for site initiation; Negotiate and execute clinical site and ancillary agreements; Define and implement study start-up strategies at project level; Proactively identify and mitigate risks impacting timelines; Build relationships with clients, regulatory authorities, and internal stakeholders; Monitor project budgets and hours; Assist in securing new business by developing regulatory sections of proposals and budgets; Provide coaching and performance feedback to team members.
Seniority
Manager, hands-on leadership